MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.The product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Dr.(b)(6) was trailing the 3mm poly trial bearing at the end of the case.He put the knee in a full range of motion.He then used the bearing trial removal tool to take out the trial.While removing it the trial broke.

Event Description

Dr.(b)(6) was trialing the 3mm poly trial bearing at the end of the case.He put the knee in a full range of motion.He then used the bearing trial removal tool to take out the trial.While removing it the trial broke.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 9 complaints reported with the item.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device not returned.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: visual inspection of returned product confirms the reported event (instrument fracture).The trial bearing shows signs of wear in line with use during its time in the field (approximately 11 years).The dimensional check was not conducted as the product was damaged on return and this has no impact on the reported event.A review of manufacturing history records confirms no abnormalities or deviations were reported.The dhr review showed that all released products are according to specifications valid at the time of production.The device is used for treatment.A compatibility review was not applicable to this evaluation.Complaint history review for 32-422703 identified eight (8) previous complaints.Medical records/radiographs are not applicable to this evaluation.The likely condition of the device when it left zimmer biomet is conforming to the specification.The definitive root cause of the reported event cannot be determined with the information provided, however, wear and tear and end of lifespan are likely to be contributing factors.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: dr (b)(6) was trialling the 3mm poly trial bearing at the end of the case.He put the knee in a full range of motion.He then used the bearing trial removal tool to take out the trial, while removing it the trial broke.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12116234
• MDR Text Key: 261681287
• Report Number: 3002806535-2021-00294
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346813
• UDI-Public: 05019279346813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: 351100
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female